Aerobic exercise and hypoglycaemia (low blood sugar) after Roux-en-Y gastric bypass

Not Applicable

• Conditions: The effect of exercise on recovery from gastric bypass surgery; Not Applicable

• Registration Number: ISRCTN17674908
• Lead Sponsor: niversity of Leicester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-29
• Last Update Posted: 22 January 2024
• Study Completion: 2024-10-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Aged >=18 years but less than 75 years
2. Subjects >=1 year after gastric bypass (RYGB)
3. Able to understand written and spoken English
4. Able to provide informed consent

Exclusion Criteria

Current exclusion criteria as of 19/01/2023:
1. A current diagnosis of type 2 diabetes (defined as HbA1C =6.5% at screening blood tests or HbA1C <6.5% at screening bloods but on glucose-lowering medications over last 3 months)
2. An eGFR value of <=30 ml/min over the last 6 months
3. History of revisional bariatric surgery, except of previous gastric banding which has been removed
4. Any other bariatric operation which is not RYGB (single anastomosis bypass patients will be excluded)
5. On any medications that affect glucose levels (e.g. glucose-lowering medications or steroids)
6. Any contraindications/limitations to AEX self-reported or identified in the maximal exercise test (e.g orthopaedic limitations, severe cardiovascular/pulmonary disease, chair bound)
7. An established diagnosis of PHH
8. Systolic blood pressure > = 160mmHg or Diastolic blood pressure > = 100mmHg at screening
9. Individuals which are taking part in regular structured exercise
10. Being on acarbose, diazoxide, octreotide or other treatment for postprandial hypoglycaemia
11. History of epilepsy
12. HbA1C >=6.5% or >=48 mmol/l at screening blood tests
13. Haemoglobin (Hb) <100 g/L at screening blood tests
14. Currently pregnant or breastfeeding
15. Recent active infection (over the last 10 days)
16. Adrenal insufficiency and/or substitution with glucocorticoids
17. >180 kg at screening due to the maximum weight capacity of the treadmill
18. Participating in another research study involving intervention within 3 months of screening

Previous exclusion criteria:
1. A history of diabetes mellitus (type 1 or type 2 diabetes mellitus)
2. An eGFR value of <=30 ml/min over the last 6 months
3. History of revisional bariatric surgery, except of previous gastric banding which has been removed
4. Any other bariatric operation which is not RYGB (single anastomosis bypass patients will be excluded)
5. On any medications that affect glucose levels (e.g. glucose-lowering medications or steroids)
6. Any contraindications/limitations to AEX self-reported or identified in the maximal exercise test (e.g orthopaedic limitations, severe cardiovascular/pulmonary disease, chair bound)
7. An established diagnosis of PHH
8. Systolic blood pressure > = 160mmHg or Diastolic blood pressure > = 100mmHg at screening
9. Individuals which are taking part in regular structured exercise
10. Being on acarbose, diazoxide, octreotide or other treatment for postprandial hypoglycaemia
11. History of epilepsy
12. HbA1C >=6.5% or >=48 mmol/l at screening blood tests
13. Haemoglobin (Hb) <100 g/L at screening blood tests
14. Currently pregnant or breastfeeding
15. Recent active infection (over the last 10 days)
16. Adrenal insufficiency and/or substitution with glucocorticoids
17. >180 kg at screening due to the maximum weight capacity of the treadmill
18. Participating in another research study involving intervention within 3 months of screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified